Why potentially vital monoclonal antibodies go unused



[ad_1]

SAN DIEGO (KGTV) – There is only one licensed treatment designed to keep patients at high risk of COVID-19 away from hospital, but hundreds of thousands of doses of the same experimental therapy given to the former President Donald Trump are stored.

Flooded hospitals were slow to administer monoclonal antibodies due to what an infectious disease specialist called a “perfect storm” of complicating factors. Some healthcare providers have refused doses completely.

These challenges include personnel and space limitations during the skyrocketing cases, the time required to deliver an infusion, and the short window providers must have to reach eligible patients for treatment.

Still, federal and state health officials have urged providers to expand access to the experimental therapy, which has shown promise in preliminary trials. A clinical trial of the monoclonal antibody cocktail made by Regeneron found that hospital admissions fell to 3% from 9% in the group that received a placebo.

At family health centers in San Diego, they converted a dentist’s office and unused medical space into a monoclonal antibody infusion clinic.

“I think we need to do all we can to keep our hospitals from being overwhelmed,” Deputy Medical Director Dr Christian Ramers said.

Dr Ramers said he and two assistants infused about five patients a day with the lab-made antibodies, four days a week. They plan to expand the operation to serve up to eight patients per day, but the clinic for low-income patients already does more infusions than some large hospitals.

“Interestingly, the offer isn’t the problem. This is another case where hundreds of doses of this drug are being placed in refrigerators all over San Diego County, ”he said.

At the end of last month, the Department of Health and Human Services said 378,000 doses of monoclonal antibodies had been distributed to hospitals and clinics in the county. Only 20 percent of the supply had been used.

Regeneron and a second company, Eli Lilly, obtained emergency use authorizations in November to treat people at high risk of serious illness on an outpatient basis, before someone was admitted to hospital.

The drug itself is free, with thousands of doses paid for by the federal government.

“Everyone thought it would stop as soon as they went to the centers. But unfortunately due to a perfect storm of things. It didn’t really pick up that much, ”said Dr. Peter Chin-Hong, an infectious disease specialist at UC San Francisco.

Some hospitals have avoided treatment because the data is limited. The National Institutes of Health says there is “not enough data” to recommend or against drugs. Clinical trials are still ongoing.

The infusions take two hours for the patient, plus additional preparation time to thaw and mix the solution. It’s a challenge at a time when the staff is tight.

“It’s the middle of a wave right now and there aren’t a lot of people around,” Dr Chin-Hong said. He said UCSF was doing about two to four infusions a day.

There is also a narrow window of time to administer the treatment. Under the FDA’s Emergency Use Clearance, qualified patients must receive the antibodies within 10 days of onset of symptoms.

Dr Ramers said the average patient could wait a few days for a test and then wait a few more days for results. At that point, “you’re already pushing the end of that window, so there’s a lot of work to do to identify people very quickly.”

Family health centers have developed an algorithm to scan its positive tests for the best candidates, so that they can quickly contact these patients and try to make an appointment for the long treatment.

They target people over 65 or with risk factors like obesity, diabetes, lung disease and other conditions.

Due to the need to quickly analyze medical history and test results, family health centers can only offer monoclonal antibodies to existing patients who test positive at one of its clinics, the family health center said. Dr Ramers.

But he said other providers were offering the treatment. Patients just need to know how to ask.



[ad_2]

Source link